Filing Variations

Description

January 1 2010 the implementation of the new variations regulation (EC) 1234/2008, which applies to marketing authorisations granted through the mutual recognition process, decentralised or centralised procedure.

Informaâ€™s Filing Variations Conference in June will be the optimal time to assess how both industry and Regulatory Authorities have adapted to the new regulation 18 months on.

There are major benefits for industry if the new regulation is used effectively â€“ lower waiting queues for filing variations, clearer requirements, more flexibility and efficient post market surveillance.